NITI Aayog Weighs New Framework for Medical Device Sector
NITI Aayog has commenced formal evaluations regarding fresh policy interventions aimed at expanding domestic production capabilities for medical and dental equipment. The public policy advisory body convened a multi-stakeholder consultation session to investigate structural cost disadvantages, infrastructure shortfalls, and regulatory bottlenecks affecting domestic engineering firms. Chaired by NITI Aayog vice chairman Ashok Lahiri, the session brought together administrative officials from federal health and pharmaceutical ministries alongside engineering specialists and commercial trade operators.
Regulatory proposals would reduce Notified Body audits of manufacturing sites from 90 days to 30 days and final licensing decisions from 45 days to 20 days after receiving the inspection report.
Multi-Agency Deliberations And Institutional Representation
The policy review drew participation from key administrative divisions, including the Department of Pharmaceuticals, the Ministry of Health, the Department of Science and Technology, and the Indian Council of Medical Research. Technical expertise was provided by academic researchers from the Indian Institute of Technology in Delhi and Mumbai, while digital trade platforms dealing in dental supplies also took part. Discussions centered on establishing collaborative frameworks between state organs and private industry to shape recommendations that align with broader national health objectives and long-term economic targets.
Under the Scheme for Promotion of Medical Devices Parks, three parks have been approved in Greater Noida, Ujjain, and Kanchipuram with total project costs over ₹871.11 crore and Central assistance of ₹100 crore each.
Government health data indicates out-of-pocket spending accounts for about 75% of cancer treatment expenses in India, while the medical device market historically depended on imports for more than 85% of supplies.
Industry Demands For Dedicated Legislation And Relief
Representing domestic producers, the Association of Indian Medical Device Industry submitted formal proposals calling for standalone statutory legislation governing medical technology alongside streamlined clearance procedures. The industry association highlighted that administrative hurdles have severely prolonged establishment timelines for new production facilities. According to industry figures, setting up a manufacturing plant which historically required roughly 18 months now stretches across nearly four years due to proliferating approvals, overlapping jurisdictional authorities, and shifting compliance mandates.
Under the medical devices PLI scheme, a total of 28 applicants have been approved and an incentive amount of ₹157.15 crore has been disbursed to seven applicants through December 2025.
Under the medical device manufacturing promotion scheme, 24 greenfield projects have been commissioned and production has started for 57 products, generating cumulative eligible sales of Rs. 13,624.52 crore through December 2025.
Structural Cost Disadvantages And Local Infrastructure Gaps
Domestic device manufacturers currently operate at an estimated 10 to 15 percent cost handicap when pitted against imported alternatives. This structural disadvantage is driven by elevated capital costs, expensive energy supplies, burdensome logistics expenses, and restricted access to risk capital. Furthermore, producers face severe deficits in domestic testing facilities and research infrastructure. Industry representatives underscored that mitigating these financial and infrastructural penalties remains essential for curbing heavy import reliance and strengthening local healthcare supply chains.
Broader Economic Roadmap And Human Capital Targets
In related policy commentary regarding national growth, Ashok Kumar Lahiri noted that India requires accelerated structural reforms to achieve high-income status by 2047. Lahiri emphasized that human capital development through targeted improvements in healthcare and education forms the bedrock of productivity and long-term economic performance. Pointing out that India's per capita income currently rests at approximately 2,813 dollars, Lahiri stated that reaching projected high-income thresholds between 18,000 and 20,000 dollars over the next two decades demands consistent economic momentum modeled after high-growth Asian economies.